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Sponsored by: |
Sosei |
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Information provided by: | Sosei |
ClinicalTrials.gov Identifier: | NCT00635063 |
Purpose:
The purpose of this study is to compare the efficacy and safety of AD 923 to the most widely used current treatment (MSIR) in the management of target BTP in subjects with malignancies who are taking a stable dose of background opioids. The efficacy evaluation criteria have been designed to determine whether AD 923 provides superior analgesia compared with MSIR as measured by the primary endpoint.
Condition | Intervention | Phase |
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Cancer Pain |
Drug: AD 923 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Multicentre, Randomised, Double-Blind, Double-Dummy, Crossover Study to Evaluate the Safety and Efficacy of AD 923 (Fentanyl Sublingual) in Comparison to Morphine Sulphate Immediate Release (MSIR) for the Treatment of Breakthrough Pain in Subjects With Malignancies |
Estimated Enrollment: | 150 |
Study Start Date: | February 2008 |
Arms | Assigned Interventions |
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AD 923: Experimental | Drug: AD 923 |
MSIR: Active Comparator | Drug: AD 923 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Responsible Party: | Sosei R&D Ltd ( Dr Robin Bannister ) |
Study ID Numbers: | P-AD923-005 |
Study First Received: | March 4, 2008 |
Last Updated: | June 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00635063 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Belgium: Federal Agency for Medicinal Products and Health Products; Romania: National Medicines Agency; Spain: Spanish Agency of Medicines; Netherlands: Medicines Evaluation Board (MEB) |
Cancer Breakthrough Pain |
Morphine Fentanyl Pain |